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Completed

NCT Number: NCT01043913

Guarana (Paullinia Cupana) for Breast Cancer Chemotherapy-related Fatigue

The investigators hypothesize that Guaraná, a native plant from the Amazon, might improve chemotherapy-induced fatigue in breast cancer patients undergoing treatment. In order to assess this, the investigators randomized patients to either guaraná extract or to placebo, switching the assigned treatment mid-term through the cycles of Chemotherapy.

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Key information

Conditions

Signs and Symptoms Breast Diseases Breast Neoplasms Fatigue Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060650, Brazil

About this study

The aim of this study is evaluate the favourable effects of Guaraná in quality of life and Fatigue in patients undergoing Chemotherapy treatment for Breast Cancer. After approval by our Institutional Review Board, we included consenting patients with a histological diagnosis of Breast Cancer for whom Chemotherapy was indicated.

Patients who agreed to participate in the study were submitted initially to a screening interview with the Brief Fatigue Inventory questionnaire from MD Anderson. If the patient presented with a severe fatigue, anemia (HB<11.0), hypothyroidism or psychiatric disorders she was excluded. If she presented with a mild or moderate fatigue the follow up continued and the patient was assessed 21 days later after her first cycle of chemotherapy with the same questionnaire. If an increase in fatigue levels occurred from mild to moderate, mild to severe or moderate to severe the patient was randomly assigned to receive either Guaraná 50mg or a placebo p.o. q12 for 21 days. At this moment the patient answered a General questionnaire, FACIT-F, FACIT-ES, HADS, Pittsburgh Sleep Quality Index and Chalder Fatigue Questionnaire (Day 1).

After the second cycle of chemotherapy the patient underwent a "wash out" period of 7 days without any intervention, and after that period she received placebo or Guaraná according to the cross over design after answering for the second time the questionnaires above (Day 29) and also the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). After 21 days (Day 42) she was assessed again with the same questionnaires used in the second interview.

The patient's cancer diagnosis, treatment history, concurrent medication was recorded during the pretreatment and The Brief Fatigue Inventory was answered before each assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological diagnosis of Breast Cancer
  • Patients undergoing Chemotherapy (First Cycle)
  • 18 years old or older

Exclusion criteria

  • Hypothyroidism
  • Clinical Depression
  • Prior Chemotherapy
  • Anemia
  • Unable to sign informed consent
  • Severe Fatigue

Treatment and study plan

Guarana extract

Drug

Guarana extract 50mg q12 hours for 21 days

Other names: Paullinia Cupana

Primary outcomes

  1. Fatigue improvement between the baseline to D21 or from D21 to D42 measured by Chalder Fatigue Scale, FACT-F and FACT-ES questionnaires

    Time frame: 42 days

Secondary outcomes

  1. To access the quality of life between the baseline to D21 or from D21 to D42 measured by FACT-F and FACT ES questionnaires

    Time frame: 42 days

Sponsors and collaborators

Lead sponsor

Faculdade de Medicina do ABC

Other

Registry information

Official study title

Guaraná ("Paullinia Cupana") for Chemotherapy Related Fatigue in Breast Cancer Patients: Results Of A Pilot Double Blind Randomized Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 7, 2010
Registry last updated
Jan 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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